1. Field of the Invention
The present invention pertains to an apparatus and method which enable vertical banded gastroplasty to be performed without the use of staples, and preferably laparoscopically.
2. Description of the Background Art
Morbid obesity is a significant health problem in the United States, affecting over four million people. Morbid obesity occurs when the obesity is sufficient to prevent normal activity or physiologic function, or is sufficient to cause onset of a pathologic condition. (Morbid obesity is strictly defined as 80 lbs or more overweight for women and 100 lbs or more overweight for men). People who are morbidly obese are more than ten times as likely to die each year as normal age matched controls. The death rate for patients with morbid obesity is about 2.5% per year. In addition to the health risks, the socioeconomic and psychological effects of morbid obesity are significant. The only known effective long term therapy for morbid obesity is surgical, since dieting may allow the morbidly obese to lose weight but this loss is almost always temporary.
Several surgical procedures are available for treatment of morbid obesity, but the most commonly performed is Vertical Banded Gastroplasty (VBG). In VBG, an upper gastric pouch is formed within the stomach, using the stomach walls for the reconstruction. The upper pouch is formed using a vertical staple line, with a band (typically Silastic.RTM. or Marlex.RTM.) applied to prevent dilation of the outlet from the upper pouch into the remaining portion of the stomach. Since bodily sensors which cause a person to feel "full" are located in the area in which this upper gastric pouch is formed, as the upper pouch stretches to contact the sensors, the person tends to stop eating. VBG has a mortality rate of about 0.5% and is effective in long term (a period of 5 years or more) weight loss for the majority of patients. The statistically small, but significant, risks of VBG have been more than outweighed by the decreased mortality rate of morbidly obese persons after surgery. However, it is standard practice of physicians to restrict the VBG procedure to persons who are morbidly obese, due to the statistically significant risks involved.
A large portion of the morbidity attributed to VBG is related to respiratory and wound complications in this medically at risk population. It would be, then, highly desirable to have a laparoscopic procedure to accomplish VBG in order to reduce wound complications, pain, recovery time, and length of bed rest related to the surgery. Advantages of the laparoscopic procedure should include faster recovery, decreased respiratory and wound complications, decreased post-operative pain and decreased scarring.
One of the more significant barriers to performance of a laparoscopic VBG has been the absence of an adequate stapling device for use under laparoscopic conditions. A 90 mm stapler having a straight line construction design is generally used in the open surgical procedure. A stapler of this dimension and design could not be used in laparoscopic surgery in which the diameter of the opening ports into which surgical instruments are inserted ranges from about 5 mm to about 35 mm.
U.S. Pat. No. 5,170,925 to Madden et al., issued Dec. 15, 1992, discloses a laparoscopic stapler with knife means. A four-row laparoscopic surgical stapler cutting mechanism is described wherein stapling and cutting are remotely accomplished. Particular means which enable closure and stapling of the apparatus are described. Closure of the apparatus can take place either using a lever or a collar type means. Another automatic stapler for laparoscopic procedure is disclosed in U.S. Pat. No. 5,104,394 to Knoepfler, issued Apr. 14, 1992. In particular, this patent describes an improved surgical stapler which includes a cutter adapted to cut items grasped by the stapler jaws and a suctioning tube at the tip of the apparatus. This improved stapler permits a surgeon to staple and subsequently selectively cut without removing the apparatus. Still another apparatus for placing staples in laparoscopic or endoscopic procedures in described in U.S. Pat. No. 5,040,715 to Green et al., issued Aug. 20, 1991. This patent describes a surgical stapler for placing lateral lines of staples and making an incision, all through an endoscopic tube.
Although the development of such stapling devices permits laparoscopic placement of staple lines, they do not provide for the placement of a 90 mm staple line nor for placement of the band at the outlet of the pouch formed by the stapling of the stomach walls.
Conventional VBG requires that a circular hole be made in the stomach to allow for placement of the vertical staple line and horizontal band. This circular hole is usually accomplished using a stapling/cutting device that removes a circular portion of stomach and places several circular rows of staples. This configuration of staple placement is difficult to perform laparoscopically and makes it more difficult to reverse the procedure should this be necessary. Thus, it would be desirable to have a device and method which would permit performance of VBG without the use of a circular opening and staple configuration.
Further, patient experience has demonstrated numerous incidents pertaining to VBG, by any surgical procedure, wherein staples have become detached from the stomach, causing a gradual opening of the pouch into the entire stomach.
Thus, it would be desirable to have an alternative to the stapling procedure for formation of the upper gastric pouch. Even more desirable would be an alternative procedure wherein the band at the outlet of the pouch was formed simultaneously with the pouch. Such an alternative procedure performed laparoscopically might enable reduction of the mortality rate for VBG to a level such that the procedure could be made available to individuals who do not fall into the morbidly obese category, but who have a sufficiently significant overweight condition that their health is adversely affected.